Fibrosis Scanning Probe

Basic Information

• Brand Name: Fibrosis Scanning Probe
• Primary DI: 06971679947023
• Version / Model: FT-2.5D9
• Company Name: Wuxi Hisky Medical Technologies Co.,Ltd.
• Labeler DUNS: 544348534
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-31
• Public Version: 1
• Public Version Date: 2020-04-08
• Public Version Status: New
• Public Device Record Key: 13d8714b-6d1f-4a66-ae7a-01c850b5e95d

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58711	Hepatic ultrasound elastography system applicator	A non-sterile hand-held device designed to be used for the transcutaneous measurement of liver stiffness based on transient elastography. It includes an ultrasound transducer and an electrodynamic transducer intended to generate a controlled transient vibration that produces a mechanical elastic shear wave propagated through the skin and liver; subsequent ultrasound measurements can be used to calculate a measure of liver stiffness/ultrasonic attenuation of tissues. The device is designed to connect to a control unit and may be available in various forms for different applications [e.g., paediatric, bariatric (obese)]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06971679947023	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K173595	000
K200136	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 30 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 86 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 0 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -5 – 40 Degrees Celsius